Weekly Roundup – 9-16-11

September 16, 2011

Someone has flipped a switch and turned summer off and autumn on as we dove down in temperature to the 40s last night. It is a most welcome change sending us all in search of our corduroys as we weed the linens out of the closet. Such a busy time of year.

Regardless of the season, our world marches on and here were a few highlights from the week I thought worth noting:

FDA Reorganizes Oncology – The Center for Drug Evaluation and Research (CDER) announced this week that it was reorganizing and renaming the Office of Oncology Drug Products. The old office contained three divisions while the new one has four within its ranks and it will now be called the Office of Hematology and Oncology Products (OHOP). The reason there are now four is that the Division of Oncology Drug Products (DODP) is now being transitioned into two Divisions of Oncology Products – DOP 1 and DOP 2. Jurisdiction over products is divided up by types of cancer and both will consider products whether they are drug based or biologics. DOP 1 will have jurisdiction over breast, gynecologic, genitourinary and supportive care (non-hematologic). DOP 2 will oversee gastrointestingal, lung, head/neck, neuro-oncology, rare cancers, pediatric solid tumor, and melanoma/sarcoma. You can read about other changes in the release on the change..

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About This Blog

Eye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.